USPTO Patents Application 10551504

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(43) SRS^IM B (10) HRg^MS^

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(51) HRM#8f #fi 7 : A61K 47/18, 9/20, 47/26, 47/42, 47/36

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3t#*t (DAINIPPON PHARMACEUTICAL
CO., LTD.) [JP/JP]; =r 541-8524 *IKJfr *IKTfT
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(75) nw*/amx (*HfcoiNT(D^): sea sis

(IWATA,Motokazu) [JP/JP]; T 569-1024 ^ IK Jfr IS
8fS #^fflT27#26-§- Osaka (JP). §Q li (FU-
JITA,Megiimi) [JP/JP]; T 520-2101 III *
rfT W0J4T B 2#13# Shiga (JP). |j| BB 31 St (KU-
RITA,Hideo) [JP/JP] ; T 664-0847 & J* H ^ftrfi H
y *2T @ l#40-404-^- Hyogo (JP). >f ft fit - fi|S

(KIYOSHIMA,Kenichiro) [JP/JP]; =f 651-1301 J^JtH
#P rfi dbBBUS^dbBj 5T § 3-7-802 Hyogo (JP).

(74) ft 9 A: >nIS , H(KAWAMIYA,Osamu et al.); T

540-0001 *REJfr *IKm **B«*iTB3#7fl-iMP

f »Ujt#l+*SFJf Osaka (JP).

(81) ffiffiB fH ): AE, AG, AL, AM, AT, AU, AZ, BA, BB,
BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK,
DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, HR,
HU, ID, IL, IN, IS, JP, KE, KG, KR, KZ, LC, LK, LR, LS,
LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NI,
NO, NZ, OM, PG, PH, PL, PT, RO, RU, SC, SD, SE, SG,
SK, SL, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ,
VC, VN, YU, ZA, ZM, ZW.

(84) tl^ll ARIPO (GH, GM, KE, LS, MW, MZ,

SD, SL, SZ, TZ, UG, ZM, ZW), 2"7V7S!f (AM,
AZ, BY, KG, KZ, MD, RU, TJ, TM), 3 — □ V /t&K-
(AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB,
GR, HU, IE, IT, LU, MC, NL, PT, RO, SE, SI, SK, TR),
OAPI Jftjft (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW,
ML, MR, NE, SN, TD, TG).

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(54) Title: STABILIZED COMPOSITION

(54) SSHJJCD«ffc: £SflS«J*!|*l

(57) Abstract: It is intended to provide a composition containing a substance capable of supplying aldehyde-like substances to be
used in the field of drugs, cosmetics, hair care products, etc., that contains a low-molecular weight active substance the stability of
^T) which is worsened by the effects of aldehydes together with a stabilizer having an amine structure and being capable of absorbing
aldehydes and has an improved stability to aldehydes of the low-molecular weight active substance the stability of which is worsened
by the effects of aldehydes; and a method of stabilizing such a low-molecular weight active substance. As examples of the above-de-
scribed stabilizer, aminosugars and polymers thereof, aminosugar alcohols and polymers thereof, amino acids and polymers thereof,
proteins and hydrolysates thereof, alkylamines, hydroxyalkylamines and salts thereof can be cited.

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WO 2004/037293

PCT/JP2003/013419

INTERNATIONAL. SEARCH REPORT

International application No.

PCT/JP03/13419

A. CLASSIFICATION OF SUBJECT MATTER

Int. CI 7 A61K47/18, A61K9/20, A61K47/26, A61K47/42, A61K47/36

According to International Patent Classification (IPC) or to both national classification and IPC

B. FIELDS SEARCHED

Minimum documentation searched (classification system followed by classification symbols)
Int. CI 7 A61K47/00, A61K9/00

Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched

Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)
JOIS

C. DOCUMENTS CONSIDERED TO BE RELEVANT

Category*

Citation of document, with indication, where appropriate, of the relevant passages

Relevant to claim No.

X

WO 02/32402 Al (CAMBRIDGE BIOSTABILITY LTD.),
25 April, 2002 (25.04.02),

Full text; page 3, lines 25 to 29; page 12, lines

5 ot 11; page 14; example 2; Fig. 1

6 US 6190701 A & AU 2001/11986 B
& EP 1328255 Al

1-20

X

WO 01/74397 Al (KIRIN BEER KABUSHIKI KAISHA) ,
11 October, 2001 (11.10.01),

Full text; Claims 1, 9, 10; examples 1 to 10
& AU 2001/44584 B & EP 1273306 Al
& JP 2001-572139 A

1-20

| x | Further documents are listed in the continuation of Box C.

| | See patent family annex.

* Special categories of cited documents:

"A" document defining the general state of the art which is not

considered to be of particular relevance
"E M earlier document but published on or after the international filing

date

"L" document which may throw doubts on priority claim(s) or which is
cited to establish the publication date of another citation or other
special reason (as specified)

"O m document referring to an oral disclosure, use, exhibition or other
means

"P" document published prior to the international filing date but later
than the priority date claimed

"T" later document published after the international filing date or

priority date and not in conflict with the application but cited to
understand the principle or theory underlying the invention

"X" document of particular relevance; the claimed invention cannot be
considered novel or cannot be considered to involve an inventive
step when the document is taken alone

"Y" document of particular relevance; the claimed invention cannot be
considered to involve an inventive step when the document is
combined with one or more other such documents, such
combination being obvious to a person skilled in the art

"&" document member of the same patent family

Date of the actual completion of the international search
20 January, 2004 (20.01.04)

Date of mailing of the international search report

10 February, 2004 (10.02.04)

Name and mailing address of the ISA/

Japanese Patent Office

Authorized officer

Facsimile No.

Telephone No.

Form PCT/ISA/210 (second sheet) (July 1998)

INTERNATIONAL SEARCH REPORT

International application No.

PCT/JP03/13419

C (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT

Category*

Citation of document, with indication, where appropriate, of the relevant passages

Relevant to claim No.

X

JP 1-279843 A (Juridical Foundation The
Chemo-Sero-Therapeutic Research Institute) ,
10 November, 1989 (10.11.89),

Full text; Claims; page 4; referential example 4
(Family: none)

1-20

X

JP 60-161925 A (Sanwa Kagaku Kenkyusho Co.,
Ltd. ) ,

23 August, 1985 (23.08.85),

Full text; Claims; page o, preparation examples
1/ 2

(Family: none)

1-20

*

A

JP 8-291071 A ( YAMANOUCH I PHARM. CO., LTD.).
05 November, 1996 (05.11.96),
Full text; Claims; examples
(Family: none)

1-20

A

WO 01/28571 Al (NIPPI INC.),

2 6 April, 2001 (26.04.01),

Full text; Claims; examples 3 to 12

& JP 2001-122790 A & EP 1224937 Al

1-20

A

JP 60-233011 A (Ajinomoto Co., Inc.),
19 November, 1985 (19.11.85),
Full text; examples 1 to 3
(Family: none)

1-20

A

WO 01/43762 Al (LILLY & CO., ELI.),
21 June, 2001 (21.06.01),
Full text; Claim 35

& JP 2001-181203 A & AU 2001/20493 B
& EP 1242121 Al & JP 20U3—DZ397Z A
& US 2003/207802 A

1-20

X

WO 01/1096 Al (SHAPIRO KABUSHIKI KAISHA) ,
12 January, 1995 (12.01.95),
Full text; Claim 9

& AU 9472144 B & EP 707446 Al
& JP 8-512055 A & US 5668117 A

1-20

X

WO 96/14365 A2 (WARNER LAMBERT CO.),
17 May, 1996 (17.05.96) ,

Full text; Claims; page 1, line 24 to page 2,
line 5

& US 5620704 A & EP 791037 Al
& JP 10-509470 A

1-20

P, X

JP 2003-55263 A (Fuji Capsule Kabushiki Kaisha) ,
26 February, 2003 (26.02.03),
Full text; examples 1 to 4
(Family: none)

1-20

Form PCT/ISA/210 (continuation of second sheet) (July 1998)

INTERNATIONAL SEARCH REPORT

International application No.

PCT/JP03/13419

<Subject of search>

Concerning "a low-molecular weight active substance the stability
of which is worsened by the effects of aldehydes'' directly or indirectly
specified in each claim, the restriction with unclear extent
"low-molecular weight'' is merely presented but no clear definition is
made in claims or description how large molecules fall within the' category
of "low-molecular weight". Even though the common technical knowledge
at the point of the application is taken into consideration, it is
inherently unclear what "substance the stability of which is worsened
by the effects of aldehydes" means and the scope thereof cannot be
specified- Such being the case,- each claim does not comply with the
requirement of clearness in accordance with PCT Article 6.

In this report, therefore, the search was made mainly on compositions
containing physiologically active substances which had been clarified
as being worsened in stability by the effects of aldehydes regardless
of molecular sizes thereof as the above "low-molecular weight active
substance" and the report is based on the results.

Form PCT/ISA/210 (extra sheet) (July 1998)

PC T/ JP03/13419

A. 3B9!©JR-rs^»o^SS (H(R*Sfff#« (IPC) )

Int. CI 7 A61K47/18, A61K9/20, A61K47/26, A61K47/42, A61K47/36

£Stfrofc*/hlKR3pF mWMW^m (IPC) )

Int. CI 7 A61K47/00, A61K9/00

JOIS

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X

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ZfcSfc^fts p. 3^25-29fT, p. 1205-llff . p. 14 EXAMPLE 2, Figure
1 & US 6190701 A & AU 2001/11986 B & EP 1328255 Al

1-20

X

WO 01/74397 Al (KIRIN BEER KK) 2001. 10. 11 XWt'&i^ ft*
©*BH1,9,1(K ^fM&Jl-10 & AU 2001/44584 B & EP 1273306
Al & JP 2001-572139 A

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001-3 (7r5!J-ftU

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m35 & JP 2001-181203 A & AU 2001/20493 B & EP 1242121

Al P. TP OAAQ K0QO70 A P. TTC OAHO /OdHQClO A

Al & Jr ZUUo O/oy / Z A & Uo ZUUo/ZU/oUZ A

1-20

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WO 95/1096 Al (SHAPIRO H K) 1995. 01. 12 Ifcj&fc^fts clalm9
& AU 9472144 B & EP 707446 Al & JP 8-512055 A & US
5668117 A

1-20

X

WO 96/14365 A2 (WARNER LAMBERT CO) 1996. 05. 17 :£iSfc£fts c
laims, p. H2*ff-p. 2H5?f & US 5620704 A & EP 791037
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1-20

P, x

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